510(k) K850170
K850170 is an FDA 510(k) premarket notification submitted by Cardiac Resucitator Corp. for the device "HEART AID MODEL 97". The FDA issued a decision of Substantially Equivalent on February 14, 1985. The device falls under product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)), a Class II device regulated under 21 CFR 870.5550. Cardiac Resucitator Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 1985
- Date Received
- January 16, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- Device Class
- Class II
- Regulation Number
- 870.5550
- Review Panel
- CV
- Submission Type